How to Track Regulatory Correspondence in Kivo
Tracking agency commitments is essential for obvious reasons, but can be stressful without a system or process to manage them. With Kivo'sCorrespondence Tracking,you'll never have to...
How to Review and Approved Controlled Documents in Kivo
Document authoring is one of the most essential activities in Regulatory, Clinical, and Quality operations. Regulations such as CFR Part 11 requiring compliant e-Signatures dictate the way...
How to Manage Projects Efficiently with Automated Reporting
One of the more challenging aspects of clinical trial management is visibility. The sheer number of outsourced partners - sites, CROs, writers, consultants, vendors, etc - who often have...
A Guide to Regulatory Submissions in the US (FDA) & EU (EMA)
If you're new to regulatory submissions, they can seem a little confusing - and not just because there are some many acronyms to learn. To help you navigate the landscape, we offer this...
How to Manage Regulatory Projects and Content Plans in Kivo
Regulatory content planning is a foundational step for any regulatory submission. A regulatory content plan is a outline of the pieces of content required for the submission, their due...
Accelerate Quality Operations with Automatic Quality Templates
Quality operations, by definition, follow repeatable processes. Therefore, finding small-but-meaningful ways to accelerate these processes can add up to large time savings over time, and...
An Overview of ICH Guidelines
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, or simply ICH, stands as a cornerstone in the realm of pharmaceutical development...
How to Link Documents Directly to your eCTD Submission
Imagine you have assembled your regulatory submission after months (or even years!) of effort. It is now time to send it to a publisher to compile into the correct format for submission to...
TMF Breakdown: What Constitutes a Trial Master File?
At the heart of clinical trial documentation lies the Trial Master File (TMF), a comprehensive repository of essential documents and data pertaining to the trial. Let’s discuss this...
Recent FDA News: End of 2023 Summary
Happy new year folks!
Kivo GO Feature Round Up: Clinical Updates
Rounding out our Feature Round Up series, this article will showcase some of the new clinical capabilities of our eTMF. To read more about the overall features of Kivo GO, our new Quality...
Kivo GO Feature Round Up: Regulatory Updates
Alongside the launch of our QMS, we’ve also made some big improvements to our regulatory management capabilities. In this article, we’ll outline what’s new and how those changes can...